MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX OXYGEN AND MEDICATION DELIVERY CONNECTOR; CONNECTOR, AIRWAY (EXTENSION)

Model Number	66-1991
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the it was so challenging for the doctor to remove the scope from the swivel connector, the device sheared.Concomitant medical products/therapies reported were: (b)(4).There has been no report of patient injury or no observable clinical symptoms or a change in symptoms identified in the patient.
Additional Manufacturer Narrative
Device manufacture date and 510k are unknown, no information has been provided to date.Investigation, including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
Other, other text: additional information is provided in h.2., and h.6.Product was not returned, and no photographic evidence provided to aid in this investigation.As a result, product evaluation and problem confirmation cannot be performed.The root cause for this event is unknown.No lot number reported for the device history record review to be performed for all enquiries or follow-up questions related to the record, do not use regulatory.Responses@smiths-medical.Com located in sections g.1., please direct those to the following: regulatory.Responses@icumed.Com.

• Brand Name: PORTEX OXYGEN AND MEDICATION DELIVERY CONNECTOR
• Common Device Name: CONNECTOR, AIRWAY (EXTENSION)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): NULL; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16472896
• Report Number: 3012307300-2023-01949
• Device Sequence Number: 12697224
• Product Code: BZA
• UDI-Device Identifier: 10788942619913
• UDI-Public: 10788942619913
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 66-1991
• Device Catalogue Number: 66-1991
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2023
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 03/02/2023
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown